FDA.reportPublic FDA data

Geo ArcB Scanbody Kit

Primary DI
08800028740467
Brand
Geo ArcB Scanbody Kit
Company
GEOMEDI INC.
Model
ABSK-SET-D
Device description
This product is a kit consisting of dental implant surgical instruments and a screw driver. It is used after implant superstructure or Multi-screw abutment placement and serves as an abutment-level scan body for intraoral digital impression taking in full-arch prosthetic fabrication.
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800028740467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800028740467088000287404678800028740467

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694173762
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800028740320Geo ArcB ScanbodyArcB-3017N-22026-06-25
08800028740337Geo ArcB ScanbodyArcB-3021N-22026-06-25
08800028740344Geo ArcB ScanbodyArcB-3025N-22026-06-25
08800028740351Geo Impression Direct CopingIPDC-5070MN2026-06-25
08800028740450Geo ArcB Scanbody KitABSK-SET-C2026-06-25
08800028713126Geo CMFit AbutmentCMFit10-3ICM-H22026-05-06
08800028713133Geo CMFit AbutmentCMFit14-3ICM-H22026-05-06
08800028713140Geo CMFit AbutmentCMFit10-3ICR-H22026-05-06
08800028713157Geo CMFit AbutmentCMFit14-3ICR-H22026-05-06
08800028713881Geo CMFit AbutmentCMFit10-3IC60-H22026-05-06
08800028713898Geo CMFit AbutmentCMFit10-3ICW-H22026-05-06
08800028714475Geo CMFit AbutmentCMFit14-3IC60-H22026-05-06
08800028714482Geo CMFit AbutmentCMFit14-3ICW-H22026-05-06
08800028715649Geo Multibase AbutmentLL2-3ICM-H22026-05-06
08800028715656Geo Multibase AbutmentLL2-3ICM-N22026-05-06
08800028715663Geo Multibase AbutmentLL2-3ICR-H22026-05-06
08800028715670Geo Multibase AbutmentLL2-3ICR-N22026-05-06
08800028715687Geo Multibase AbutmentLL2-3IC60-H22026-05-06
08800028715694Geo Multibase AbutmentLL2-3IC60-N22026-05-06
08800028715700Geo Multibase AbutmentLL2-3ICW-H22026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016108774Dental Implants Accesseories-ReusableCowellmedi Co.,LtdNDP2026-07-28
08800076476271T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-27
D7702682153RIGHT ANGLE SCREWDRIVER FORSWEDEN & MARTINA SPANDP2026-07-27
D7702698973DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702698983DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702750843INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
D7702750853INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
03701045246374KONTACTBIOTECH DENTALNDP2026-07-24
03701045246381KontactBIOTECH DENTALNDP2026-07-24
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14